IHI European HealthCare Incubator Network

Type of action: HORIZON JU Research and Innovation Actions (HORIZON-JU-RIA) Consortium: standard Horizon Europe rule for this type of action, at least three independent legal entities from three different member or associated states, unless the call document says otherwise. Expected Impact: The action under this topic is expected to achieve the following impacts and contribute to the following EU policies/initiatives: deliver innovative, early technology solutions that contribute to addressing strategic unmet public health needs across multiple therapy areas to improve prevention, early diagnosis, and treatment; leverage the unique network and scale of IHI JU members to create a pipeline to support innovative startups in the health industry, fully integrated into European initiatives in support of start-ups and entrepreneurship; drive early cross-sector health R&D and innovation to strengthen the European healthcare industry’s global competitiveness, contributing to the EU Industrial Strategy and Pharmaceutical Strategy objectives; create a sustainable network of European healthcare incubators to guide and support highly talented and innovative early-stage companies; harness digital health and data-sharing technologies (e.g., AI and big data) to enable interoperable health solutions, contributing to the European Health Data Space (EHDS) and improved evidence based care;- the action should generate a portfolio of early‑stage companies that have undergone rigorous multi‑industry validation, significantly increasing their credibility with investors, regulators, and healthcare systems. This ‘industry quality seal’ should enhance the selected startups’ ability to secure follow‑on financing;   by integrating corporate expertise into a pan‑European incubator network, the action should reduce fragmentation, support faster clinical and eventually commercial decision‑making, and enable more innovators to navigate regulatory and reimbursement pathways successfully. This should contribute to the objectives of the EU to accelerate the translation of research into deployable health technologies. The Network should serve as a feeder mechanism into wider EU support structures, ensuring that promising companies can transition smoothly into later‑stage funding and scale‑up opportunities. This complementarity should maximise the added value of EU public funding while avoiding duplication and reinforcing Europe’s position as a globally competitive hub for health innovation. The action under this topic should synergise with relevant EU programmes and contribute to several key EU strategies and policies: Life Science strategy, the proposed Biotech Act (especially the biotechnology development accelerators as referred to in article 5 of the Commission proposal), Industrial strategy, Pharmaceutical strategy, EU4Health Programme, Digital Europe Programme, Testing and Experimental Facility for Health AI and Robotic (TEF-Health), European Innovation Council (EIC) programmes, EU Competitive Compass, Choose Europe initiative, Startup and Scale-up strategy by the European Commission. Additionally, the action under this topic should synergise with the forthcoming European Startup and Scaleup Hubs and, in particular, encourage connection into the Network from the Call ‘European Startup and Scaleup Hub Pilot Call – HORIZON-EIE-2026-02-CONNECT-01’. Furthermore, the action has the potential to support Europe’s Beating Cancer Plan, EU Mission on Cancer, Healthier Together – EU Non-Communicable diseases initiative, Joint Action for Cardiovascular Disease and Diabetes in Europe, or the Cardiovascular Health Plan. Applicants should demonstrate in the proposal how these synergies will avoid duplication, ensure complementarity with existing EU efforts, and provide early-stage companies with continuity and scale up pathways. Expected Outcome: This call topic responds to the pressing need for a collaborative approach to accelerating the research-to-market pathway and fostering innovation and competitiveness in the European healthcare sector. Accordingly, the action under this topic must contribute to all of the following outcomes: 1. A sustainable European HealthCare Incubator Network (hereafter, the ‘Network’) linking incubators from the public sector (academia, foundations etc.) and industry (pharma, medtech, biotech) to leverage and catalyse otherwise fragmented efforts and increase the reach of early-stage healthcare companies and academic players across Europe. By providing tailored mentorship and networking, resources and funding mechanisms, the Network will identify high-potential innovations and establish clear pathways for the scale-up and sustainable development of early-stage healthcare companies, supporting the next wave of European innovations. 2. A strong programme for de-risking pipelines and mentoring high potential start-ups, with the objective of making start-ups more attractive as investment propositions, and more capable of attracting essential scale-up finance through private or public investors. This should be achieved by leveraging the Network’s unique access to multi-sectorial corporate expertise and mentorship from multiple large-cap companies with tailored funding. 3. An agile framework for funding promising start-ups through the mechanism of Financial Support to Third Parties (‘FSTP’ or ‘cascade funding’). 4. Access to high-quality services and infrastructures, provided by the consortium, to accelerate the most promising innovations. 5. A framework of collaboration with other relevant funding and innovation programmes (e.g. the European Innovation Council (EIC), EIT Health, and national and regional initiatives) to raise selected start-ups’ awareness of potential future additional opportunities for support. 6. An ‘industry quality seal’ marking industry-validated promising start-ups, de-risked and connected to potential future funders and venture capital funds, that should enhance their ability to secure follow‑on financing and successful further development. 7. New opportunities for strategic partnerships between selected start-ups and partner companies, incubators, investors, venture capital funds, and other interested third parties. 8. A portfolio of early-stage companies with improved business, market and technological readiness. This is achieved through targeted access to expertise, infrastructure and services, mentorship, training, and FSTP-supported resources, culminating in sustainable innovations that can be implemented at scale. The immediate and direct relationship between start-ups and the Network creates not only a support mechanism for start-ups, but also a coordinated platform delivering high value, non-financial industrial expertise that is not available through existing EU funding instruments. Definitions for the purpose of this call topic: Early-stage company: Early-stage company / start-up refers to a new, fast-growing business that is typically in the early stages of development [1]. The Technology Readiness Level (TRL) is a scale (from TRL 1 to TRL 9) used to assess the maturity of a technology or innovation. For the purpose of the topic, only early-stage companies at TRL 3 to TRL 5 are considered, meaning those in the early-stage development phase, where the technology is still being refined but has moved beyond basic concepts. The table below gives more specific examples. Type of product TRL 3 TRL 4 TRL 5 A medical device Initial proof of concept demonstrated with a limited number of in vitro & in vivo trials including the expected device characteristics. Proof of concept and safety of the device is demonstrated in vitro, ex vivo or in vivo conditions (non-GMP, Good Manufacturing Practice). System components integrated and tested regarding preliminary efficiency and reliability. Pre-clinical studies include GLP (good laboratory practice), animal safety, and toxicity. GMP manufacturing process and quality controls identified. Classification of the device by the appropriate regulatory body established. Accreditation when appropriate initiated. A drug Initial proof of concept demonstrated with a limited number of in vitro & in vivo models. Proof of concept and safety of the candidate is demonstrated in a laboratory or animal model. Pre-clinical studies including GLP, animal safety & toxicity to support the Investigational New Drug (IND) application or similar EU process. Incubator means an organisation that provides support and resources to early-stage companies to help them grow, develop their business models, and succeed. Incubators offer services like office and lab space, mentorship, training, and access to networks of investors and professional services. Private or public funder means an investor who provides grants and/or capital to early-stage, high‑growth potential companies in exchange for equity. A Venture Capital (‘VC’) investment as an example, offers a combination of funding and strategic support, such as business guidance and industry connections, to help new companies grow and achieve a significant return on investment. A relevant example of a public funder is the European Innovation Council Accelerator [2]. [1] In line with the European Commission recommendation on the definition of innovative enterprises, innovative startups and innovative scaleups: https://research-and-innovation.ec.europa.eu/document/download/4e3cd140-47ed-4de2-be02-af1f344a2990_nl [2] https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en Scope: Specific Challenges Europe has world-class research especially in the field of healthcare but continues to lag in commercialising its scientific output. This negatively impacts timely access to novel health technologies for European patients and healthcare systems, especially in areas of unmet healthcare need. Early-stage companies, which are the main engines of innovation, struggle due to structural barriers that inhibit innovation and scale-up. In general, early-stage companies often lack structured support, impeding their development and survival. The EU is positioning itself as a strategic hub for innovative start-ups/ early stage companies by launching several key initiatives and funding instruments to this end, such as the Start-up and Scale-up Strategy [1] and the Scale-up Europe Fund [2]. Additionally, Europe is rich in public incubators dedicated to healthcare start-ups, and many healthcare industry stakeholders have established dedicated incubators/venture accelerators. However, the landscape of such initiatives, both public and private, is fragmented and not easily accessible to all early-stage companies across Europe, nor is it able to provide the necessary know-how and support at a scale that is necessary for generating a step change in bringing innovations to market in Europe and increasing Europe’s competitiveness. Consequently, the whole healthcare ecosystem is negatively impacted. Investors face difficulty identifying scalable ventures in a fragmented landscape. Industry lacks opportunities for early engagement with meaningful innovative projects that will bring novel therapies and medical technologies to patients. Additionally, regulators and policymakers must balance public safety with the need to reduce delays and complexity for innovators. This, in turn makes it very difficult for young and inexperienced innovators, who often lack relevant knowhow, to navigate the regulatory framework. Ultimately, this implies that European health systems and patients are missing out on timely access to innovative diagnostics and treatments. Objectives The overall aim of this call topic is to create a European HealthCare Incubator Network (‘the Network’) that should address the above challenges by delivering a structured support framework to enable more effective progression of outputs of early-stage healthcare companies toward deployable innovations in the healthcare ecosystem. The Network should create a unique, multi-sectorial network of business leaders and funders across the whole health industry and be exceptionally well placed to provide cross-industry business support and networking to promising start-ups. In practice, this should be achieved by providing both financial support (via FSTP) and direct interactions with large-cap pharmaceutical and medical technology industries/ companies. The opportunities for start-ups to engage with major pharmaceutical and med‑tech companies are unique within the Network, while remaining fully complementary to other EU funding instruments (e.g., the EIC). The applicants in their proposal should ensure that through its design, the Network will: Provide early, industry-informed insights into whether a start-up’s concept or product has the potential to address an unmet clinical/healthcare need and therefore represents a viable market opportunity. Offer access to specialised mentorship and coaching, including expertise from large-cap pharma and med‑tech on pre-clinical development, regulatory pathways, market access considerations, and overall technology maturation. Facilitate potential access to industrial capital, facilities, and infrastructural resources. Connect start-ups with high-quality early-stage innovators across the ecosystem, stimulating collaboration and shared learning. Strengthen fundraising prospects through association with leading industry partners as well as enhanced visibility By fostering a cohesive, innovation-friendly ecosystem, the action should aim to foster retention of talent, reinforce Europe’s technological leadership, and improve access to novel health technologies for patients and healthcare systems. The action generated from this topic should help to bridge the first ‘valley of death’ in innovation [3], where promising technologies often fail due to lack of funding, know‑how, and support mechanisms for reaching clinical efficacy and regulatory readiness. The objectives of the topic are in response to IHI JU Strategic Research and Innovation Agenda (SRIA) [4] specific objective 2 - Integrate fragmented health research and innovation efforts by bringing together health industry sectors and other stakeholders. This will enable the development of tools, data, platforms, technologies and processes that will in turn facilitate the prevention, diagnosis, treatment and management of diseases, especially in areas where there is an unmet public health need. The applicants are expected to address all the following strategic objectives in their proposal: Objective 1 – Establishment and governance of a Europe-wide Incubator Network: The Network should establish a lean and effective governance structure for the action with clear operational processes and collaboration mechanisms among the project partners and stakeholders (universities, industry, regulators, funders, other incubators etc), with the ultimate mission of guiding the selected start-ups and boosting the uptake of their innovative solutions into healthcare systems. Activities to be performed in the context of this objective: Establish the Network Coordination Forum (composition, terms of reference, meeting cadence) as the main governing and decision-making body of the consortium, including an even split between public and private partners. Establish an Advisory Board (AB) to provide advice on the Network’s activities including: the implementation of the eligibility and award criteria, the nomination of independent experts in the FSTP evaluation committee, and the overall evaluation process for awarding the FSTP. The AB should include representatives from relevant European Commission Executive Agencies such as the European Innovation Council (EIC), and independent experts with relevant European-wide innovation expertise. Develop a formal EU incubator network partner map as well as a mechanism for collaborating with further incubators as relevant. Create and update throughout the duration of the action an integration plan detailing how existing incubators are connected and leveraged. Objective 2 – Selection & monitoring: Attract, identify, evaluate, fund and monitor a project portfolio of high-potential early-stage healthcare companies selected through open, competitive, widely published calls that conform to EU standards concerning transparency, equal treatment, conflict of interest and confidentiality. Activities to be performed in the context of this objective: Prepare and implement the call, publish and launch the first call by month 6, and co-ordinate the evaluation and selection of third parties in line with the ‘Financial Support to Third Parties (FSTP)’ section of this topic; publish and launch additional calls as needed. Implement objective criteria when an additional milestone-based follow-on grant could be made available to accelerate development, validation, and industrial uptake. Establish a standardised contract template for third-party engagements via FSTP (including the relevant Intellectual Property (IP) considerations such as measures to safeguard it), milestone-based funding release schedules and clear oversight/audit protocols. Prepare a transparent onboarding workflow for early-stage companies funded through the project (timelines, governance guardrails). Objective 3 – Growth catalyst: Develop a comprehensive infrastructure support programme for early-stage companies that receive funding by providing mentoring, access to infrastructure, business development resources and regulatory navigation (CE marking, European Medicines Agency (EMA) processes, Medical Device Regulation / In Vitro Diagnostic Regulation (MDR/IVDR)); and training on commercial readiness ((pre)clinical validation, reimbursement strategies, business model development). By fostering early regulatory preparedness, the action should aim to improve time-to-market and increase the likelihood of regulatory acceptance of the outputs of the activities supported via FSTP. Activities to be performed in the context of this objective: Create a mentoring programme for the FSTP recipients. The mentoring programme should be performed by expert consortium members. The applicants should identify a structure, mentor rota, matching process, milestones and evaluation for the mentoring programme. The mentoring programme is free of charge for the FSTP recipients, and additional to the FSTP funding. Provide regulatory navigation support (e.g. regulatory guidance on CE marking and clinical evidence generation, support with General Data Protection Regulation (GDPR) and ethical approvals, CE/ EMA pathway support, MDR/ IVDR training). Early engagement with regulators, such as EMA and national authorities, should be actively promoted and facilitated. Provide mentoring for (pre)clinical validation, go-to-market planning, reimbursement strategies and commercial considerations. Such mentoring should be delivered by relevant experts from the pre identified industry consortium and contributing partners. Provide expertise related to securing investments and ensuring readiness for commercialisation and market deployment (market research, value proposition, business case and business model, prospects for growth, intellectual property protection, competitor analysis etc.). Provide access to infrastructures, facilities and specialised services, thereby strengthening selected start-ups’ research and development capacity, accelerating technology maturation and validation, and supporting the translation of innovative ideas into robust, market-relevant solutions. Build up an infrastructure access catalogue (labs, equipment, shared services) and hybrid R&D options. Design and implement visibility, outreach and networking opportunities for the selected start-ups, to match them with relevant venture capital funds, big buyers, accelerators and other industry players within and outside the consortium, with the final objective of providing growth and/or exit opportunities t